Documentation Systems Coordinator
815 Tek Dr Crystal Lake, IL 60014 US
Responsible for the administration of site training quality system and conducting new-hire orientation. Role includes (but is not limited to): data entry of training records, management of curricula and user groups, system reporting, acting as Subject Matter Expert (SME).
Furthmore this position will be working with our Engineering and Quality Departments, creating change orders, revising existing documentation, inspecting and post-approving artwork, and documentation associated with lab el changes to our product packaging. This position supports one or more mid to senior-level managers and works in a diverse and complex environment inclusive of some customer and executive contact. This role creates red line documents and enters into the AGILE Document Control Program and routing for approval. Duties may include more complex administrative activities including managing project tasks, composing letters and reports, preparing / editing presentations, critical thinking/investigative skills, and recommending or making purchase decisions are included in the responsibilities of this role. This role is responsible for the comparison of approved graphics to vendor proof's and the review / comparison of graphic files to technical documentation as defined by the Documentation Cente
Presentation skills including comfort in speaking in front of large groups, communicating effectively with various site functional groups.Adminstration of electronic learning system (myLearning). Manage and track training status and other training QMS deliverable
Attention to detail including Graphic, Alpha and Numeric. Manage and track Graphics and their approvals. Edit and revise Tech. Spec. using Word, Excel and AGILE. Manage and track revised spec. and their approvals. Organize and maintain work flow to establish priorities. Possesses strong written and verbal communication skills. Intermediate to advanced computer skills including word processing, spreadsheet, and basic presentation or database applications and may train others. Must be able to work autonomous with limited direction. Preferred Skills/Qualifications Experience using Microsoft Office Software Skills/Competencies Ability to express ideas both in written and oral communications
Three years of experience preferably in a medical manufacturing industry
Understanding of FDA regulations surrounding the manufacture of medical devices and GMP
Education required/ preferred High School Diploma required preferred Associates Degree from a two-year college or technical school or equivalent experience.